MAUDE Adverse Event Report: E.C. MOORE CO. SPARKLE FREE PROPHY PASTE; PROPHYLAXIS PASTE

Model Number UPSFMC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Rash (2033); Local Reaction (2035)

Event Date 03/27/2019

Event Type  Injury  

Manufacturer Narrative

A facility reported that a patient experienced an allergic reaction after a routine dental cleaning using sparkle free prophy paste.Crosstex followed up with the facility for more information.It was reported the patient experienced symptoms of redness and a rash around her mouth.It was reported that the symptoms lasted for more than two weeks and she is currently under medical supervision.Crosstex confirmed with the manufacturer of sparkle free prophy paste, e.C.Moore co., that there have been no changes to the formula or production procedures.The sparkle free prophy paste safety data sheet (sds) states that this product may cause skin irritation.This complaint will continue to be monitored in the crosstex complaint handling system.

Event Description

A facility reported that a patient experienced an allergic reaction after a routine dental cleaning using sparkle free prophy paste.

• Brand Name: SPARKLE FREE PROPHY PASTE
• Type of Device: PROPHYLAXIS PASTE
• Manufacturer (Section D): E.C. MOORE CO.; 13325 leonard st; dearborn MI 48126
• Manufacturer (Section G): E.C MOORE CO.; 13325 leonard st; dearborn MI 48126
• Manufacturer Contact: hannah shrader ; 10 ranick road; hauppauge, NY 11788 ; 7635596863
• MDR Report Key: 8557045
• MDR Text Key: 143385408
• Report Number: 2433773-2019-00002
• Device Sequence Number: 1
• Product Code: EJR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UPSFMC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other